Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery

Corneal Neovascularization Clinical Trial

Official title:

Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769145
• Other study ID #: 20071015
• Status: Completed
• Phase: Phase 1
• First received: October 7, 2008
• Last updated: July 7, 2017
• Start date: October 2008
• Est. completion date: March 2012

Study information

• Verified date: July 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing corneal transplantation.

Description:

As a secondary objective, this study also aims to establish the corneal and anterior chamber concentration of ranibizumab when delivered subconjunctivally at the limbus in patients undergoing corneal transplantation. The effects of ranibizumab on corneal epithelial healing will be examined following adjunctive use in corneal transplantation. Finally, clinical characteristics including recurrent corneal neovascularization will be studied.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

Subjects will be eligible if the following criteria are met:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study

• Age > 18 years

• Patient related considerations

• All patients of both genders will be considered for enrollment.

• Disease related considerations

• Patients meeting accepted criteria for undergoing corneal transplantation will be considered if peripheral corneal neovascularization exists in 2 or more contiguous clock hours

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from this study:

• Pregnancy (positive pregnancy test)

• Women seeking to become pregnant

• Lactating women

• Prior enrollment in the study

• Prior glaucoma surgery in the region of the corneal neovascularization

• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated

• Participation in another simultaneous medical investigation or trial

Related Conditions & MeSH terms

• Corneal Neovascularization
• Neovascularization, Pathologic

Intervention

Drug:
• Ranibizumab
0.5mg subconjunctival dose of ranibizumab 3 days prior to corneal transplantation and at the time of corneal transplantation (total 2 injections).

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing corneal transplantation.		2 years
Secondary	This study also aims to establish the corneal and anterior chamber concentration of ranibizumab when delivered subconjunctivally. The effects of ranibizumab on corneal epithelial healing and prevention of recurrent neovascularization will be examined.		2 years